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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016859
Receipt No. R000016113
Scientific Title Prospective Study of Reduced Port Surgery Combined with Transvaginal Specimen Extraction for Colorectal Cancer Resection
Date of disclosure of the study information 2015/03/21
Last modified on 2015/09/22

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Basic information
Public title Prospective Study of Reduced Port Surgery Combined with Transvaginal Specimen Extraction for Colorectal Cancer Resection
Acronym Prospective Study of Reduced Port Surgery Combined with Transvaginal Specimen Extraction for Colorectal Cancer Resection
Scientific Title Prospective Study of Reduced Port Surgery Combined with Transvaginal Specimen Extraction for Colorectal Cancer Resection
Scientific Title:Acronym Prospective Study of Reduced Port Surgery Combined with Transvaginal Specimen Extraction for Colorectal Cancer Resection
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of Reduced Port Surgery combined with transvaginal specimen extraction for colorectal cancer resection in multicenter prospective study
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Safety
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Reduced Port Surgery Combined with Transvaginal Specimen Extraction for Colorectal Cancer Resection
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Female
Key inclusion criteria (1) colorectal cancer patients undergoing elective surgery
(2) histologically proven colorectal carcinoma
(3) tumor located in the sigmoid colon or rectosigmoid colon
(4) Stage 0-I, according to the TNM classification system
(5) age >= 20 and <= 80 years, no willing to bear children, previous childbirth with vaginal delivery
(6) without any gynecological comorbidities need to be treated
(7) vaginal examination shows no inadequate conditions for transvaginal specimen extraction such as stenosis of vagina
(8) no history of diseases which could cause pelvic adhesion such as pelvic peritonitis
(9) PS (ECOG) 0 or 1
(10) no history of gastrointestinal resection (except appendectomy)
(11) no history of chemotherapy or radiotherapy for other cancers
(12) no preoperative chemotherapy or radiotherapy
(13) with a good condition of important organs
1. WBC : >= 3,000/mm3
2. platelet >= 100,000/mm3
3. serum creatinine <= 1.5mg/dL
4. ALT/AST <= 5-times the upper limit of normal in facility criteria
(14) provided written informed consent
Key exclusion criteria (1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
(2) with uncontrolled diabetes mellitus (including the case requiring insulin administration)
(3) with uncontrolled congestive heart disease, ischemic heart disease, hypertension or arhythmia
(4) severe mental disease
(5) not appropriate for the study at the physician's assessment
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichiro Takemasa
Organization Graduate School of Medicine, Osaka University
Division name Department of Gastroenterological Surgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3251
Email itakemasa@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Hamabe
Organization Graduate School of Medicine, Osaka University
Division name Department of Gastroenterological Surgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3251
Homepage URL
Email ahamabe@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor National Cancer Center Hospital East
Osaka Medical College, Department of General and Gastrocnterological Surgery
Shinko Hospital
Tonan Hospital
Nagaoka Chuo General Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2014 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 21 Day
Last modified on
2015 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016113

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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